Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00931385
First received: July 1, 2009
Last updated: November 15, 2010
Last verified: November 2010

July 1, 2009
November 15, 2010
June 2009
April 2010   (final data collection date for primary outcome measure)
The primary objective will be to evaluate whether once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device is superior to once daily treatment with Placebo Respimat using FEV1 AUC values [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
The primary objective will be to evaluate whether once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device is superior to once daily treatment with Placebo Respimat using FEV1 AUC values [ Time Frame: 6 Weeks ]
Complete list of historical versions of study NCT00931385 on ClinicalTrials.gov Archive Site
  • Additional Pulmonary Measures with FEV1, FVC, FEV1 AUC. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Labs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • The secondary objective will be to compare once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device to twice daily treatment with Foradil Aerolizer using FEV1 AUC values. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The key secondary objective will be to compare once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device to twice daily treatment with Foradil Aerolizer using FEV1 AUC values. Additional pulmonary and safety measures [ Time Frame: 6 weeks ]
Not Provided
Not Provided
 
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil Iin Patients With Chronic Obstructive Pulmonary Disease

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: BI 1744
    BI1744 Respimat Med Dose Once Daily
  • Drug: bi1744
    1744 low dose
  • Drug: Placebo
    Placebo Respimat and Foradil Placebo
  • Drug: Foradil
    Foradil 12 mcg twice daily and Placebo Respimat
  • Experimental: BI 1744 (Olodaterol) Low Dose
    BI1744 Low Dose once daily
    Intervention: Drug: bi1744
  • Experimental: BI 1744 (Olodaterol) Med Dose
    BI 1744 Med Dose once daily
    Intervention: Drug: BI 1744
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Drug: Placebo
  • Active Comparator: Foradil
    Foradil 12 mcg twice daily
    Intervention: Drug: Foradil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
Not Provided
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients willing to participate with confirmed diagnosis of COPD
  • 40 years of age or older
  • having a 10 pack year smoking history
  • able to perform serial pulmonary function tests
  • able to use both a DPI and Respimat device

Exclusion Criteria:

  • Significant other disease
  • clinically relevant abnormal hematology, chemistry, or urinalysis
  • history of asthma
  • diagnosis of thyrotoxicosis
  • paroxysmal tachycardia related to beta agonists
  • history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
  • active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
  • significant alcohol or drug use
  • pulmonary resection
  • taking oral beta adrenergics
  • taking unstable oral steroids
  • daytime oxygen
  • enrolled in rehabilitation program
  • enrolled in another study or taking investigational products
  • pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
  • those who are not willing to comply with pulmonary medication washouts
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00931385
1222.24
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP